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Item 7. Management’s Discussion and Analysis

2025-03-27 compared with 2024-03-28 · 278 added, 268 removed, 389 unchanged (58% of the section changed)

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Introduction to PDS Biotechnology Corporation

We are a clinical-stage immunotherapy company developing a growing pipeline of targeted cancer and infectious disease immunotherapies based on our Versamune®, Versamune® in

combination with our IL-12 fused anti-body drug conjugate (ADC) PDS01ADC (formerly known as PDS0301/M9241/NHS-IL-12) and Infectimune® T cell-activating platforms and PDS01ADC tumor targeting immunocytokine.

We believe our targeted

immunotherapies have the potential to overcome the limitations of current immunotherapy approaches through the activation of the right type, quantity and potency of T cells.

Versamune®, and Versamune® in combination with PDS01ADC are utilized

for treatments in oncology and Infectimune®, for treatments in infectious disease.

When paired with an antigen, which is a disease-related protein that is recognizable by the immune system, Versamune® and Infectimune® have both been shown to

induce, in vivo, large quantities of high-quality, highly potent polyfunctional CD4 helper and CD8 killer T cells, a specific sub-type of T cell that is more effective at killing infected or target

Infectimune® is also designed to promote the induction of disease-specific neutralizing antibodies.

PDS01ADC is an investigational tumor targeting IL-12 that we believe may enhance the proliferation, potency and longevity of T cells in

the tumor microenvironment.

Based on preclinical studies and recent investigational clinical data, we believe that Versamune® in combination with PDS01ADC may enhance the proliferation, potency and longevity of antigen specific multifunctional

CD8 T cells in the tumor microenvironment and work synergistically to overcome tumor immune suppression.

In July 2022, we announced the presentation of universal flu vaccine preclinical data for PDS0202 at the 41 st American

Society of Virology meeting:

Abstract number 3733830, Infectimune®™ enhances antibodies elicited by COBRA hemagglutinin influenza vaccine.

In November 2022, we announced the presentation of data from two Phase 2 clinical trials at the 37 th Annual

Meeting for the Society of Immunotherapy of Cancer (SITC):

Abstract number 674, IMMUNOCERV, an ongoing Phase 2 trial combining PDS0101, an HPV-specific T cell immunotherapy, with chemotherapy and radiation for treatment of locally advanced

cervical cancers and abstract number 695, Immune correlates associated with clinical benefit in patients with checkpoint refractory HPV-associated malignancies treated with triple combination immunotherapy.

We are a clinical-stage immunotherapy company developing a growing pipeline of targeted cancer immunotherapies based on our Versamune®, Versamune® in combination with our IL-12

fused anti-body drug conjugate (ADC) PDS01ADC (formerly known as PDS0301/M9241/NHS-IL-12).

In addition, we are developing the Infectimune® T cell-activator in infectious diseases.

We believe our targeted immunotherapies have the potential to

overcome the limitations of current immunotherapy approaches through the activation of the right type, quantity and potency of T cells.

Versamune®, and Versamune® in combination with PDS01ADC are utilized for treatments in oncology and

Infectimune®, for treatments in infectious disease.

When paired with an antigen, which is a disease-related protein that is recognizable by the immune system, Versamune® and Infectimune® have both been shown to induce, in vivo, large quantities of high-quality, highly potent polyfunctional CD4 helper and CD8 killer T cells, a specific sub-type of T cell that is more effective at killing infected or target cells.

Infectimune® is also designed

to promote the induction of disease-specific neutralizing antibodies.

PDS01ADC is an investigational tumor targeting IL-12 that we believe may enhance the proliferation, potency and longevity of T cells in the tumor microenvironment.

preclinical studies and recent investigational clinical data, we believe that Versamune® in combination with PDS01ADC may enhance the proliferation, potency and longevity of antigen specific multifunctional CD8 T cells in the tumor

microenvironment and work synergistically to overcome tumor immune suppression.

In December 2022, we executed an exclusive global license agreement with Merck KGaA, Darmstadt, Germany for the tumor targeting IL-12 fused antibody drug conjugate, M9241, which joined our

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different mechanism from immune checkpoint inhibitors (ICI).

The combination of Versamune® and PDS01ADC to overcome immune suppression is patented by us, and we believe our ownership of both assets will

streamline the clinical development, registrational process and their potential therapeutic use.

In a Phase 2 National Cancer Institute (NCI)-led clinical trial in ICI resistant patients, the combination of

PDS0101 and PDS01ADC administered with an investigational bi-functional ICI resulted in a median overall survival of approximately 20 months.

The historical median survival reported in ICI resistant HPV-positive cancers when treated with ICIs

is 3-4 months, and best reported median survival to date with systemic therapy is 8.2 months in ICI resistant head and neck cancer.

In February 2023, we announced a successful completion of a Type B meeting with the FDA for the triple combination of PDS0101 and PDS01ADC with an FDA-approved immune

checkpoint inhibitor for the treatment of recurrent/metastatic, ICI resistant head and neck cancer that is positive for the HPV type 16.

In recent interactions with the FDA, we confirmed the required contents of a clinical protocol for the

potential registrational trial.

The potential ability of the c ombination of Versamune® and PDS01ADC to overcome immune suppression is patented by us, and we believe our ownership

of both assets will streamline the clinical development, registrational process and their potential therapeutic use.

In a Phase 2 National Cancer Institute (NCI)-led clinical trial in ICI-resistant patients, the

combination of Versamune® HPV and PDS01ADC administered with an investigational bi-functional ICI resulted in a median overall survival of approximately 20 months.

The historical median survival reported in ICI-resistant HPV-positive cancers

when treated with ICIs is 3-4 months, and best reported median survival to date with systemic therapy is 8.2 months in ICI-resistant head and neck cancer.

In February 2023, we announced the completion of a Type B meeting with the FDA for the triple combination of Versamune® HPV and PDS01ADC with an FDA-approved immune checkpoint

inhibitor for the treatment of recurrent/metastatic, ICI-resistant head and neck cancer that is positive for the HPV type 16.

In recent interactions with the FDA, we confirmed the required contents of a clinical protocol for the potential

registrational trial.

In June 2023, an abstract was presented at the 2023 American Society of Clinical Oncology:

Abstract number 6012, Safety and Efficacy of Immune Checkpoint Inhibitor (ICI) Naïve Cohort from Study

of PDS0101 and Pembrolizumab in HPV16-Positive Head and Neck Squamous Cell Carcinoma (HNSCC).

of Versamune® HPV and Pembrolizumab in HPV16-positive Head and Neck Squamous Cell Carcinoma (HNSCC).

The abstract was also selected as one of the featured posters reviewed by an expert panel in the Head and Neck Cancer discussion session.

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with lethal doses of the pandemic H1N1 flu virus.

In October 2023, data demonstrating PDS0101 in combination with standard-of-care (SOC) chemoradiotherapy was associated with a rapid decline in human papillomavirus circulating cell-free DNA

(ctHPV-DNA), a potential predictive biomarker of treatment response.

In October 2023, data demonstrating Versamune® HPV in combination with standard-of-care (SOC) chemoradiotherapy was associated with a rapid decline in human papillomavirus circulating cell-free

DNA (ctHPV-DNA), a potential predictive biomarker of treatment response.

The data from the IMMUNOCERV Phase 2 clinical trial were featured in an oral presentation at the American Society for Radiation Oncology Annual Meeting.

In October 2023, updated interim data based on an August 2 nd cut off from our VERSATILE-002 Phase 2 clinical trial

evaluating the combination of PDS0101 in combination with Merck’s anti-PD-1 therapy, Keytruda® (pembrolizumab) which is the FDA-approved standard of care for first-line treatment of recurrent/ metastatic head and neck cancer was presented at a

Company-sponsored key opinion leader roundtable.

In October 2023, updated interim data based on an August 2 cut off from our VERSATILE-002 Phase 2 clinical trial evaluating the combination of Versamune® HPV in combination with Merck’s anti-PD-1

therapy, Keytruda® (pembrolizumab) which is the FDA-approved standard of care for first-line treatment of recurrent/ metastatic head and neck cancer was presented at a Company-sponsored key opinion leader roundtable.

In October 2023, interim safety and immune response data was presented for the first-in-human Phase1/2 clinical trial evaluating PDS01ADC in combination with current SOC chemotherapy, docetaxel,

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Congress 2023.

In November 2023, we announced updated survival data from our NCI-led Phase 2 trial investigating the triple combination of PDS0101, PDS01ADC and an investigational immune checkpoint inhibitor

(ICI) in two groups of advanced cancer patients with various types of human papillomavirus (HPV) 16-positive cancers.

In November 2023, we announced updated survival data from our NCI-led Phase 2 trial investigating the triple combination of Versamune® HPV, PDS01ADC and an investigational immune checkpoint

inhibitor (ICI) in two groups of advanced cancer patients with various types of human papillomavirus (HPV) 16-positive cancers.

In November 2023, we announced updated interim survival data from our NCI-led Phase 2 triple combination trial.

In November 2023, preclinical data from our NCI-led trial including PDS0101, PDS01ADC and an HDAC inhibitor in ICI-resistant HPV-16 positive cancer was presented during a poster presentation at

the Society for Immunotherapy of Cancer 38 th Annual Meeting.

In November 2023, preclinical data from our NCI-led trial including Versamune® HPV, PDS01ADC and an HDAC inhibitor in ICI-resistant HPV-16 positive cancer was presented during a poster

presentation at the Society for Immunotherapy of Cancer 38 th Annual Meeting.

In May 2024, at a virtual key opinion leader event, updated interim data was presented based on a November 30, 2023 cut-off from our VERSATILE-002 Phase 2 clinical trial evaluating the combination of Versamune® HPV

in combination with Merck’s anti-PD-1 therapy, Keytruda® (pembrolizumab) which is an FDA-approved standard of care for first-line treatment of recurrent/metastatic head and neck cancer.

Data from 53 patients was presented.

In June 2024, we provided a data update from our VERSATILE-002 clinical trial.

Interim data was presented based on a May 17, 2024 cut-off.

In August 2024, we provided an update to our clinical strategy following discussions with the FDA.

During the August 2024 update, we announced our intent to initiate a registrational trial in first line treatment in

HPV16-positive recurrent/metastatic HNSCC with the double combination of Versamune® HPV + pembrolizumab.

In September 2024, we announced updated data from our VERSATILE-002 Phase 2 clinical trial presented during a poster session at the European Society for Medical Oncology (ESMO) Congress 2024.

In October 2024, we announced updated data from the IMMUNOCERV Phase 2 clinical trial evaluating Versamune® HPV with chemoradiation to treat locally advanced cervical cancer presented at the

American Society for Radiation Oncology (ASTRO) Annual Meeting 2024.

Clinical Candidate Pipeline

National Cancer Institute:

PDS0101+ M9241 (now PDS01ADC) +Bintrafusp Alfa

In June 2020, the first patient was dosed under a PDS0101 Cooperative Research and Development Agreement (CRADA), in the NCI led Phase 2 investigator-initiated trial evaluating PDS0101 with an

IL-12 ADC now PDS01ADC, and M7824 (Bintrafusp alfa), which is owned by EMD Serono (Merck KGaA) in patients with advanced HPV-positive cancers who have failed prior treatment.

In February 2021, the NCI’s Phase 2 clinical trial of PDS0101 for the

treatment of advanced HPV-positive cancers had achieved its preliminary objective response target in patients naïve to check point inhibitors which allowed for full enrollment of approximately 20 patients in this group.

In addition, based on

promising results in the ICI naïve arm, the trial was amended to allow enrollment of a separate cohort of IC -resistant patients for assessment of safety and activity of the triple combination.

The trial has been closed for enrollment.

Versamune® HPV + PDS01ADC + Bintrafusp Alfa

In June 2020, the first patient was dosed under a Versamune® HPV Cooperative Research and Development Agreement (CRADA), in the NCI led Phase 2 investigator-initiated trial evaluating Versamune®

HPV with an IL-12 ADC now PDS01ADC, and M7824 (Bintrafusp alfa), which is owned by EMD Serono (Merck KGaA), in patients with advanced HPV-positive cancers who have failed prior treatment.

In February 2021, the NCI’s Phase 2 clinical trial of

Versamune® HPV for the treatment of advanced HPV-positive cancers had achieved its preliminary objective response target in patients naïve to check point inhibitors which allowed for full enrollment of approximately 20 patients in this group.

addition, based on promising results in the ICI naïve arm, the trial was amended to allow enrollment of a separate cohort of ICI-resistant patients for assessment of safety and activity of the triple combination.

The trial has been closed for

Preliminary efficacy assessment of the triple combination in this added group of 29 ICI-resistant patients has been completed and evaluation of long-term patient survival is ongoing.

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therapeutic vaccine (Journal for ImmunoTherapy of Cancer2020;8:e000612.

Doi:10.1136/ jitc-2020-000612) , and indicate that PDS0101 generated both HPV-specific T cells and an associated antitumor response when used as a monotherapy.

When PDS0101 was combined with the two other novel clinical-stage anti-cancer agents, Bintrafusp Alfa and M9241 (which

is now owned by us and referred to as PDS01ADC), the preclinical data suggested that all three therapeutic agents worked synergistically to provide superior tumor T cell responses and subsequent tumor

regression when compared to any of the agents alone or the 2-component combinations.

The published preclinical data demonstrating powerful activity of the triple combination appears to be corroborated in

the Phase 2 trial, and this triple combination could form the basis of a unique platform providing improved cancer treatments across multiple cancers.

Doi:10.1136/ jitc-2020-000612) and indicate that Versamune® HPV generated both HPV-specific T cells and an associated antitumor response when used as a monotherapy.

When Versamune® HPV was combined with the two other novel clinical-stage anti-cancer agents,

Bintrafusp Alfa and M9241 (which is now owned by us and referred to as PDS01ADC), the preclinical data suggested that all three therapeutic agents worked synergistically to provide superior

tumor T cell responses and subsequent tumor regression when compared to any of the agents alone or the 2-component combinations.

The published preclinical data demonstrating powerful activity of the triple combination appears to be corroborated in the Phase 2 trial, and this triple combination could form the basis of a unique platform providing improved cancer treatments across multiple cancers.

In June 2022, at the 2022 ASCO Annual Meeting, the NCI provided an update to the preliminary data presented at the 2021 meeting (Strauss J et al.

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This included data from 30 HPV16-positive patients and highlights were as follows:

Objective response (OR = > 30% tumor reduction) was seen in 88% (7/8) of patients with ICI naive disease;

Objective response (OR = > 30% tumor reduction) was seen in 88% (7/8) of patients with ICI-naïve disease;

4/7 (57%) patients’ responses are ongoing (median 17 months).

With ICI-resistant patients:

PDS01ADC dosing appears to affect response rates, with 5/8 (63%) patients receiving PDS01ADC at 16.8 mcg/kg achieving an OR compared to 1/14 (7%) patients who received PDS01ADC

at 8 mcg/kg achieving an OR;

PDS01ADC dosing appears to affect response rates, with 5/8 (63%) patients receiving PDS01ADC at 16.8 mcg/kg achieving an OR compared to 1/14 (7%) patients who received PDS01ADC at 8

mcg/kg achieving an OR;

4/6 (67%) patients’ responses are ongoing (median 12 months).

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We believe the trial results to date strongly suggest, in agreement with the published preclinical studies, that all 3 drugs contribute to the clinical outcomes.

In September 2022, we determined, in agreement with the NCI, to select the ICI resistant patients as the preferred treatment group in the on-going PDS0101-based triple

In September 2022, we determined, in agreement with the NCI, to select the ICI-resistant patients as the preferred treatment group in the on-going Versamune® HPV - based triple

combination therapy in advanced HPV-positive cancers and the trial was closed to further enrollment given the ICI-resistant arm had been fully recruited.

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compared with approximately 70% of patients receiving the combination of ICIs and chemotherapy reporting Grade 3 and higher treatment-related AEs.

In February 2023, we announced the successful completion of a Type B meeting with the FDA for the combination therapy of PDS0101, PDS01ADC, and an FDA-approved immune

In February 2023, we announced the successful completion of a Type B meeting with the FDA for the combination therapy of Versamune® HPV, PDS01ADC, and an FDA-approved immune

checkpoint inhibitor for the treatment of recurrent/metastatic HPV-positive ICI-resistant head and neck cancer.

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VERSATILE-002:

PDS0101 + Keytruda®

In November 2020, our VERSATILE-002 Phase 2 clinical trial evaluating the combination of PDS0101 in combination with Merck’s anti-PD-1 therapy, Keytruda® (pembrolizumab) which is the

Versamune® HPV + Keytruda®

In November 2020, our VERSATILE-002 Phase 2 clinical trial evaluating the combination of Versamune® HPV in combination with Merck’s anti-PD-1 therapy, Keytruda® (pembrolizumab) which is the

FDA-approved standard of care for first-line treatment of recurrent/ metastatic head and neck cancer commenced.

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efficacy and safety of this therapeutic combination as a first and second line treatment in patients with recurrent or metastatic head and neck cancer and high-risk human papillomavirus-16 (HPV16) infection.

In this trial sponsored by PDS Biotech, patients whose cancer has returned following initial treatment or spread will be treated with the combination of PDS0101 and Keytruda® to evaluate if the addition of PDS0101 might improve the efficacy reported in published studies of Keytruda® alone.

Patients in the trial will receive a total of 5 cycles of

combination therapy in the context of standard of care Keytruda® therapy administered every three weeks until disease progression.

The primary endpoint of VERSATILE-002 is the objective response rate, or

ORR, at six months following initiation of treatment.

In this trial sponsored by us, patients whose cancer has returned following initial treatment or spread will be treated with the combination of Versamune® HPV and Keytruda®

to evaluate if the addition of Versamune® HPV might improve the efficacy reported in published studies of Keytruda® alone.

Patients in the trial will receive a total of 5 cycles of combination therapy in the

context of standard of care Keytruda® therapy administered every three weeks until disease progression.

The primary endpoint of VERSATILE-002 is the objective response rate, or ORR, at six months following

initiation of treatment.

There are two cohorts in the trial.

Cohort 1 is for patients who have yet to be treated with an immune checkpoint inhibitor (ICI naïve) and cohort 2

which consists of patients who have failed immune checkpoint inhibitor therapy (ICI resistant).

In February 2022, we achieved the preliminary efficacy milestone of at least four or more objective responses of the first 17 patients in the ICI naïve arm that allowed that arm to proceed to

full enrollment.

We also announced detailed preliminary safety data which showed that the combination is well tolerated without evidence of enhanced or significant toxicity in the first 18 patients in the ICI naïve arm.

We have completed enrollment in Stage 1 of the ICI resistant arm and we are waiting for sufficient follow up to conduct the futility analysis .

In June 2022, we presented additional preliminary efficacy and safety data from this trial at the ASCO Annual Meeting (Weiss J et al.

J Clin Oncol 40, 2022

abstr 6041)) .

The abstract provided preliminary data on 19 patients (safety) with available imaging data for 17 of the 19 patients (efficacy).

Data on 17 patients was presented.

Highlights from the abstract were as follows:

Confirmed and unconfirmed response rates thus far (tumor shrinkage greater than 30%) seen in 7/17 (41.2%) patients in comparison to the published results of approximately 19% for approved ICIs, used as monotherapy for recurrent or

metastatic head and neck cancer, with 2 of the 7 having complete responses (CR)

Stable disease (SD) was reported in 6/17 (35.3%) patients, with 4 of the 6 (67%) experiencing tumor shrinkage of less than 30%

Clinical efficacy (ORR + SD) was seen in 13/17 (76.5%) patients

Progressive/ongoing disease was reported in 4/17 (23.5%) patients

Patients had received a median of 4/5 doses of PDS0101 (range 1-5) and 9/35 doses of Keytruda® (range 1-18)

There were no treatment-related adverse events greater than or equal to Grade 3 (N=19)

No patients required dose interruption or reduction on the combination treatment

No patients discontinued the combination treatment

At 9 months of follow up (median not yet achieved):

Progression free survival (PFS) rate was 55.2%

Overall survival (OS) rate was 87.2%

no control or comparative studies have been conducted between ICIs and PDS0101

In May 2022, we expanded this trial into Europe and in June 2022, as described above, we received Fast Track designation from the U.S.

FDA for PDS0101 in combination with Keytruda®.

In August 2022, our independent Data Monitoring Committee (DMC) met and evaluated data from 43 patients and noted there were no Grade 3 or greater treatment-related adverse events attributed to

the combination.

The DMC recommended continuing the trial with no modifications.

In October 2022, we announced the results of an end-of-phase 2 meeting with the FDA for PDS0101 in combination with Keytruda®.

We have completed the plan for a potential Phase 3 clinical

program that will support the submission of a BLA for PDS0101 and have submitted our plan to the FDA.

In In May 2023, we completed enrollment in the ICI naïve arm.

Cohort 1 is for patients who have yet to be treated with an immune checkpoint inhibitor (ICI naïve) and cohort 2 which consists of patients who

have failed immune checkpoint inhibitor therapy (ICI resistant).

In May 2023, we completed enrollment in the ICI naïve arm.

We filed our amended IND with the FDA in the third quarter of 2023.

In October 2023, we received feedback from

the FDA on the amended IND.

In October 2023, we received feedback from the FDA

on the amended IND.

In June 2023, an abstract was presented at the 2023 American Society of Clinical Oncology:

Abstract number 6012, Safety and Efficacy of Immune

Checkpoint Inhibitor (ICI) Naïve Cohort from Study of PDS0101 and Pembrolizumab in HPV16-Positive Head and Neck Squamous Cell Carcinoma (HNSCC).

The abstract was also selected as one of the featured posters to be reviewed by an expert panel in

the Head and Neck Cancer discussion session.

Abstract number 6012, Safety and Efficacy of Immune Checkpoint

Inhibitor (ICI) Naïve Cohort from Study of Versamune® HPV and Pembrolizumab in HPV16-positive Head and Neck Squamous Cell Carcinoma (HNSCC).

The abstract was also selected as one of the featured posters to be reviewed by an expert panel in the

Head and Neck Cancer discussion session.

Data on 34 patients was presented.

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A disease control rate (disease stabilization or tumor shrinkage) of 70.6% (24/34)

Confirmed and unconfirmed objective response rate is 41.2% (14/34 patients), which is identical to the preliminary response rate data PDS Biotech previously reported at ASCO 2022 (7/17 patients).

To date these responses have been

confirmed in nine of the 34 patients (26.5%), including one complete response.

Confirmed and unconfirmed objective response rate is 41.2% (14/34 patients), which is identical to the preliminary response rate data previously reported by us at ASCO 2022 (7/17 patients).

To date these responses have been confirmed

in nine of the 34 patients (26.5%), including one complete response.

15/34 patients (44.1%) had stable disease.

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No Grade 4 or higher TRAEs were observed.

In October 2023, at a key opinion roundtable updated interim data was presented based on an August 2, 2023 cut-off from our VERSATILE-002 Phase 2 clinical trial evaluating the combination of PDS0101 in combination

with Merck’s anti-PD-1 therapy, Keytruda® (pembrolizumab) which is an FDA-approved standard of care for first-line treatment of recurrent/ metastatic head and neck cancer.

In October 2023, at a key opinion roundtable updated interim data was presented based on an August 2, 2023 cut-off from our VERSATILE-002 Phase 2 clinical trial evaluating the combination of

Versamune® HPV in combination with Merck’s anti-PD-1 therapy, Keytruda® (pembrolizumab) which is an FDA-approved standard of care for first-line treatment of recurrent/ metastatic head and neck cancer.

Data on 52 patients was presented.

The data from the roundtable based on

investigator assessment was as follows:

from the roundtable based on investigator assessment was as follows:

Highlights from the ICI naïve cohort include:

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The published median 12-month OS rate is 17% with no salvage chemotherapy following tumor progression on ICI (ICI Resistant).

0% (0/21) confirmed ORR suggests that PDS0101’s impact on survival does not appear to be dependent on tumor shrinkage.

0% (0/21) confirmed ORR suggests that Versamune® HPV’s impact on survival does not appear to be dependent on tumor shrinkage.

4% (1/25) of patients experienced Grade 3 TRAE and 0% (0/21) patients experienced Grade 4 and 5 TRAE.

In May 2024, at a virtual key opinion leader event, updated interim data was presented based on a November 30, 2023 cut-off from our VERSATILE-002 Phase 2 clinical trial evaluating the

combination of Versamune® HPV in combination with Merck’s anti-PD-1 therapy, Keytruda® (pembrolizumab) which is an FDA-approved standard of care for first-line treatment of recurrent/metastatic head and neck cancer.

Data from 53 patients was

The data from the event based on investigator assessment was as follows:

Highlights from the ICI naïve cohort with CPS > 1 included:

Median overall survival of 30 months;

published results for ICIs are 7-18 months.

Confirmed overall response rate ORR of 34% (18/53) to date;

published results for comparable patients receiving treatment with ICIs are less than 20%.

Confirmed complete responses, partial responses and stable disease according to RECIST v1.1 were seen in 75.5% of patients.

Median progression-free survival (PFS) of 6.3 months to date;

published results of 2-3 months PFS with approved ICIs.

The combination of Versamune® HPV and Keytruda® appeared to be well tolerated with 11% (7/62) of patients experienced Grade 3 treatment-related adverse events (TRAE) and 2% (1/62) experienced Grade 4 or 5 TRAE;

published results report

13-17% Grade 3-5 TRAE with approved ICI monotherapy.

60% (32/53) of patients had CPS score of 1-19 (who generally have a weaker response to Keytruda®), and 40% (21/53) have CPS score >20 (who generally have a higher response to Keytruda®).

In June 2024, we provided a data update from our VERSATILE-002 clinical trial.

Interim data was presented based on a May 17, 2024 cut-off.

The data update was as follows:

Median Overall Survival of 30 months, consistent with data presented our key opinion leader event in May of 2024, which was based on a data cut as of November 30, 2023.

27 of the censored patients remained alive and were awaiting their next clinical assessment, 6 censored patients had withdrawn consent for further follow-up, and 2 patients had been lost to follow-up, and 18 patients had died.

The lower limit of the 95% confidence interval is 19.7 months, and the upper limit is not yet estimable, as the majority of patients continue to be followed for survival.

In August 2024, we provided an update to our clinical strategy following discussions with the FDA.

During the August 2024 update, we announced our intent to initiate a registrational trial in

first line treatment in HPV16-positive recurrent/metastatic HNSCC with the double combination of Versamune® HPV + pembrolizumab.

In September 2024, we announced updated data from our VERSATILE-002 Phase 2 clinical trial presented during a poster session at the European Society for Medical Oncology (ESMO) Congress 2024.

The data presented was based on a May 17, 2024 data cut-off.

The main elements of the update were as follows:

Median Overall Survival (mOS) was 30 months with a lower 95% confidence interval of 19.7 months;

Published mOS for pembrolizumab is 12-18 months

Objective Response Rate (ORR) of 36% (19/53);

Published ORR for pembrolizumab is 19-25%

Disease Control Rate (DCR) is 77% (41/53)

21% (11/53) of patients had deep tumor responses and shrinkage of 90-100%

9% (5/53) of patients had a complete response

Treatment-related adverse events of Grade ≥3 were seen in 9 patients (Grade 3, n=8 and Grade 4, n=1)

MD Anderson Cancer Center (IMMUNOCERV):

PDS0101+ Chemoradiotherapy

In October 2020, a PDS0101 Phase 2 IIT was initiated with The University of Texas MD Anderson Cancer Center and is actively recruiting patients.

This clinical trial is investigating the safety

and anti-tumor efficacy of PDS0101 in combination with standard-of-care chemo-radiotherapy, or CRT, and their correlation with critical immunological biomarkers in patients with locally advanced cervical cancer.

We believe that Versamune® has

strong T cell induction with the potential to enhance efficacy of the current standard of care CRT treatment in this indication with the FDA at this meeting.

Versamune® HPV + Chemoradiotherapy

In October 2020, a Versamune® HPV Phase 2 IIT was initiated with The University of Texas MD Anderson Cancer Center and is actively recruiting patients.

This clinical trial is

investigating the safety and anti-tumor efficacy of Versamune® HPV in combination with standard-of-care chemo-radiotherapy, or CRT, and their correlation with critical immunological biomarkers in patients with locally advanced cervical cancer.

believe that Versamune® has strong T cell induction with the potential to enhance efficacy of the current standard of care CRT treatment in this indication with the FDA at this meeting.

In November 2022, data from this trial was included in a poster presentation at the 2022 SITC Annual Meeting which included the following:

9 of the 17 patients had completed a Day 170 post-treatment positron emission tomography, computed tomography (PET CT) scan to assess the status of the cancer.

This included 78% (7/9) of treated patients

with advanced cervical cancer (FIGO stage III or IV).

100% (9/9) of patients treated with the combination of PDS0101 and CRT had an objective response.

89% (8/9) of patients treated with the combination of PDS0101 and CRT demonstrated a complete response (CR) on Day 170 by PET CT.

One patient who received 3 of the 5 scheduled doses of PDS0101 showed signs

of residual disease.

This included 78% (7/9) of treated patients with

advanced cervical cancer (FIGO stage III or IV).

100% (9/9) of patients treated with the combination of Versamune® HPV and CRT had an objective response.

89% (8/9) of patients treated with the combination of Versamune® HPV and CRT demonstrated a complete response (CR) on Day 170 by PET CT.

One patient who received 3 of the 5 scheduled doses of Versamune® HPV

showed signs of residual disease.

One patient who had a CR died from an event unrelated to either their underlying disease or treatment.

1-year disease-free survival and 1-year overall survival of 89% (8/9) in patients treated with the combination of PDS0101 and CRT.

As previously reported, data confirm PDS0101 treatment activates HPV16-specific CD8 T cells.

This increase was not seen in patients who did not receive PDS0101.

The increase in HPV16-specific T cells

generated by the treatment is positively correlated with tumor cell death, suggesting cytotoxic CD8 T cells are important mediators of antigen-specific immunity.

The data affirms that PDS0101 activates Type 1 interferon pathway in humans, mimicking the mechanism previously demonstrated in preclinical studies in animal models.

Toxicity of PDS0101 remains limited to low-grade local injection site reactions.

In October 2023, data demonstrating PDS0101 in combination with standard-of-care (SOC) chemoradiotherapy was associated with a rapid decline in human papillomavirus circulating cell-free DNA

(ctHPV-DNA), a potential predictive biomarker of treatment response.

1-year disease-free survival and 1-year overall survival of 89% (8/9) in patients treated with the combination of Versamune® HPV and CRT.

As previously reported, data confirm Versamune® HPV treatment activates HPV16-specific CD8 T cells.

This increase was not seen in patients who did not receive Versamune® HPV.

The increase in HPV16-specific T

cells generated by the treatment is positively correlated with tumor cell death, suggesting cytotoxic CD8 T cells are important mediators of antigen-specific immunity.

The data affirms that Versamune® HPV activates Type 1 interferon pathway in humans, mimicking the mechanism previously demonstrated in preclinical studies in animal models.

Toxicity of Versamune® HPV remains limited to low-grade local injection site reactions.

In October 2023, data demonstrating Versamune® HPV in combination with standard-of-care (SOC) chemoradiotherapy was associated with a rapid decline in human papillomavirus circulating cell-free

DNA (ctHPV-DNA), a potential predictive biomarker of treatment response.

The data from the IMMUNOCERV Phase 2 clinical trial was featured in an oral presentation at the American Society for Radiation Oncology Annual Meeting which included the

Earlier and greater proportion of ctDNA clearance with PDS0101 plus chemoradiation (CRT) vs.

Earlier and greater proportion of ctDNA clearance with Versamune® HPV plus chemoradiation (CRT) vs.

SOC CRT alone 81.3% clearance after 3 weeks vs.

30.3% with SOC (p=0.0018), and 91.7% of clearance at 5 weeks vs.

53.1% with SOC (p=0.0179).

53.1% with SOC

Baseline ctDNA levels correlated with the International Federation of Gynecology and Obstetrics (FIGO) stage and lymph node involvement;

100% of patients treated with PDS0101 had cancer that had spread to the lymph nodes.

PDS0101 Monotherapy and in combination with Keytruda®

In February 2022, we initiated an Investigator-Initiated Trial (ITT), MC200710, for PDS0101 alone or in combination with the immune checkpoint inhibitor, Keytruda®, in

100% of patients treated with Versamune® HPV had cancer that had spread to the lymph nodes.

In October 2024, we announced updated data from the IMMUNOCERV Phase 2 clinical trial evaluating Versamune® HPV with chemoradiation to treat locally advanced cervical cancer presented at the

American Society for Radiation Oncology (ASTRO) Annual Meeting 2024 which included the following:

All patients received at least 2 doses of Versamune® HPV.

Median follow-up was 19 months.

36-month overall survival (OS) rate was 84.4%, and 100% for the eight patients who received all five doses of Versamune® HPV.

Historical published data show 36-month OS rate with chemoradiation in this

population of approximately 64%.

36-month progression free survival (PFS) rate was 74.9%, among all patients and 100% for the eight patients who received all five doses of Versamune® HPV.

Historical published data show 36-month PFS rate with

chemoradiation in this population of approximately 61%.

Complete metabolic response (CMR) was achieved in 15/17 (88%) patients.

Versamune® HPV appeared to be safe and well-tolerated.

The most common treatment-related toxicities were injection site reactions in twelve patients (71%).

Versamune® HPV Monotherapy and in combination with Keytruda®

In February 2022, we initiated an Investigator-Initiated Trial (ITT), MC200710, for Versamune® HPV alone or in combination with the immune checkpoint inhibitor, Keytruda®, in

patients with HPV-positive oropharyngeal cancer (HPV(+)OPSCC) at high risk of recurrence.

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We believe that this trial not only broadens our addressable patient population of those affected by the increasing incidence of HPV(+)OPSCC, but also allows us to better

understand the activity of PDS0101 alone or in combination with Keytruda® in earlier stages of disease.

understand the activity of Versamune® HPV alone or in combination with Keytruda® in earlier stages of disease.

This trial is currently open for enrollment.

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neoadjuvant treatment.

PDS0101 has been shown to induce killer T cells that target and kill HPV-positive cancers, either alone or in combination with ICIs in preclinical studies, and in combination in clinical studies of patients with advanced

recurrent/metastatic HPV-positive cancers.

This trial will explore whether PDS0101 with or without checkpoint inhibition may increase HPV-specific anti-tumor responses, potentially resulting in tumor shrinkage, pathologic regression, and

decreases in circulating tumor DNA (ctDNA).

Versamune® HPV has been shown to induce killer T cells that target and kill HPV-positive cancers, either alone or in combination with ICIs in preclinical studies, and in combination in clinical studies of patients with

advanced recurrent/metastatic HPV-positive cancers.

This trial will explore whether Versamune® HPV with or without checkpoint inhibition may increase HPV-specific anti-tumor responses, potentially resulting in tumor shrinkage, pathologic

regression, and decreases in circulating tumor DNA (ctDNA).

PDS0102 is an investigational immunotherapy utilizing tumor-associated and immunologically active T cell receptor gamma alternate reading framed protein (TARP) from the NCI.

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(NCT00972309).

In April 2020, the above mentioned CRADA between PDS Biotech and the NCI was expanded beyond PDS0101 to include clinical and preclinical development of PDS0103.

PDS0103 is an investigational

immune therapy owned by PDS Biotech and designed to treat cancers associated with the mucin-1, or MUC1, oncogenic protein.

In April 2020, the above-mentioned CRADA between PDS Biotech and the NCI was expanded beyond Versamune® HPV to include clinical and preclinical development of PDS0103.

PDS0103 is an

investigational immune therapy owned by us and designed to treat cancers associated with the mucin-1, or MUC1, oncogenic protein.

These include cancers such as ovarian, breast, colorectal and lung cancers.

PDS0103 combines Versamune® with novel highly

immunogenic agonist epitopes of MUC1 developed by the NCI and licensed by PDS Biotech.

PDS0103 is currently in the tech transfer, clinical scale up and manufacturing stage.

PDS0103 combines Versamune® with novel

highly immunogenic agonist epitopes of MUC1 developed by the NCI and licensed by us.

MUC1 is highly expressed in several types of cancer and has been shown to be associated with drug resistance and poor disease prognosis in breast, colorectal, lung and ovarian cancers, for which

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Expression of MUC1 is often associated with poor disease prognosis, due in part to drug resistance.

In preclinical studies, and similarly to PDS0101, PDS0103 demonstrated the ability to generate powerful MUC1-specific

CD8 killer T cells.

In the first quarter of 2022, we held a pre-IND meeting with the FDA on PDS0103 and we are prepared to submit our IND package by the end of 2024.

However, the actual submission date may

potentially be impacted by the allocation of resources to initiate a pivotal trial for PDS0101 in combination with PDS01ADC.

In preclinical studies, and similarly to Versamune® HPV, PDS0103 demonstrated the ability to generate powerful

MUC1-specific CD8 killer T cells.

In January 2025, we submitted an investigational new drug application to the FDA for a Phase 1 trial with PDS0103 and PDS01ADC in colorectal cancer.

IL-12 Oncology Immunocytokine Pipeline

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With the exclusive global license agreement with Merck KGaA, Darmstadt, Germany for PDS01ADC, we believe we have simplified our registrational pathway for the NCI-led triple combination by

owning both PDS0101 and PDS01ADC and combining these agents with an FDA approved ICI.

PDS01ADC has been designed to overcome the limitations of cytokine therapy as explained above, and based on extensive preclinical studies performed at the NCI

evaluating PDS01ADC as a monotherapy and also in combinations with established standard of care treatments for cancer, we believe that PDS01ADC has significant potential as a cytokine therapy independent of Versamune®.

Based on the informative

preclinical studies, a number of ITT Phase 2 trials are currently in progress at the NCI, some of which are outlined below:

Phase II Study Evaluating ICI Naïve and Resistant Patients with HPV-positive malignancies treated with PDS01ADC, PDS0101 and bintrafusp alfa.

A Phase II Study Evaluating T-Cell Clonality After Stereotactic Body Radiation Therapy Alone and in Combination with the Immunocytokine PDS01ADC in Localized High and Intermediate Risk Prostate Cancer Treated with Androgen

Deprivation Therapy

A Phase I/II Study of PDS01ADC in Combination with Docetaxel in Adults with Metastatic Castration Sensitive and Castration Resistant Prostate Cancer

Phase I/II of PDS01ADC going forward as a Monotherapy in Advanced Kaposi Sarcoma

Phase I/II of PDS01ADC in Combination of with a Histone Deacetylase (HDAC) Inhibitor in ICI resistant MUC1-positive colon and bladder cancers among others

owning both Versamune® HPV and PDS01ADC and combining these agents with an FDA approved ICI.

PDS01ADC has been designed to overcome the limitations of cytokine therapy as explained above, and based on extensive preclinical studies performed at

the NCI evaluating PDS01ADC as a monotherapy and also in combinations with established standard of care treatments for cancer, we believe that PDS01ADC has significant potential as a cytokine therapy independent of Versamune®.

informative preclinical studies, a number of ITT Phase 2 trials are currently in progress at the NCI, some of which are outlined below:

Phase 2 trial evaluating ICI naïve and resistant patients with HPV-positive malignancies treated with PDS01ADC, Versamune® HPV and bintrafusp alfa

A Phase 2 trial evaluating T-cell clonality after stereotactic body radiation therapy alone and in combination with the immunocytokine PDS01ADC in localized high and intermediate risk prostate cancer treated with androgen deprivation

A Phase 1/2 trial of PDS01ADC in combination with docetaxel in adults with metastatic castration sensitive and castration resistant prostate cancer

Phase 1/2 of PDS01ADC going forward as a monotherapy in advanced kaposi sarcoma

Phase 1/2 of PDS01ADC in combination of with a histone deacetylase (HDAC) inhibitor in ICI-resistant MUC1-positive colon and bladder cancers among others

In October 2023, interim safety and immune response data was presented for the first-in-human Phase1/2 clinical trial evaluating PDS01ADC in combination with current SOC chemotherapy,

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based clinical candidates.

In January 2025, we submitted an investigational new drug application to the FDA for a Phase 1 trial with PDS0103 and PDS01ADC in colorectal cancer.

Infectimune® Development Strategy

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infectious disease activities to align with the interests of the NIAID Collaborative Influenza Vaccine Innovation Centers (CIVICs) program.

This will involve development of a universal seasonal flu vaccine and the potential development of a

This may involve development of a universal seasonal flu vaccine and the potential development of a

universal pandemic influenza vaccine based on similar computationally designed antigens as have shown promise with Infectimune®.

In July 2022, universal flu vaccine preclinical data for PDS0202 at the 41 st American Society of Virology meeting:

Abstract number 3733830, Infectimune® enhances antibodies elicited by COBRA hemagglutinin influenza vaccine.

We are evaluating the next steps in the clinical development and funding for PDS0202.

The preclinical results for Infectimune® based vaccines were published in two separate articles in the peer reviewed journal Viruses in

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doses of H1N1 viruses when they were not previously exposed to flu.

Our current clinical pipeline of Versamune®, PDS01ADC and Infectimune® based therapies is as follows:

Our current clinical pipeline of Versamune® and PDS01ADC based therapies is as follows:

We have never been profitable and have incurred net losses in each year since inception.

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As of December 31, 2024, we had an accumulated deficit of $182.1 million.

Substantially all of our net losses have resulted from costs incurred in connection with our research and development programs and from general

and administrative costs associated with these operations.

Substantially all of our net losses have resulted from costs incurred in connection with our research and development programs and from general and

administrative costs associated with these operations.

As of December 31, 2024, we had $41.7 million in cash and cash equivalents.

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We have not generated any revenues from commercial product sales and do not expect to generate any such revenue in the near future.

We may, but there are no assurances that

we will, generate revenue in the future from a combination of research and development payments, product royalties, license fees and other upfront payments or milestone payments.

We may, but there are no assurances that we

will generate revenue in the future from a combination of research and development payments, product royalties, license fees and other upfront payments or milestone payments.

Research and Development Expenses

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research and development activities are expensed as incurred.

We expect that our research and development expenses will increase significantly over the next several years as we advance our Versamune® and PDS01ADC product candidates

into and through clinical trials, pursue regulatory approval of our Versamune® product candidates and prepare for a possible commercial launch, all of which will also require a significant investment in contract research services,

manufacturing process validation and inventory related costs.

We expect that our research and development expenses will increase significantly over the next several years as we advance our Versamune® and PDS01ADC product candidates into

and through clinical trials, pursue regulatory approval of our Versamune® product candidates and prepare for a possible commercial launch, all of which will also require a significant investment in contract research services, manufacturing

process validation and inventory related costs.

The process of conducting human clinical trials necessary to obtain regulatory approval is costly and time consuming.

We may never succeed in achieving marketing approval for

our clinical product candidates.

The probability of successful commercialization of our product candidates may be affected by numerous factors, including clinical data obtained in future trials, competition, manufacturing capability and

commercial viability.

As a result, we are unable to determine the duration and completion costs of our research and development projects or when and to what extent we will generate revenue from the commercialization and sale of any of our

product candidates.

We may never succeed in achieving marketing approval for our

clinical product candidates.

The following table summarizes our research and development expenses incurred for the periods indicated (in thousands):

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Clinical consulting

Cost of license rights

Salaries and other costs

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Interest Income (Expense), net

Interest income (expense), net consists of interest income earned from bank deposits and interest expense consists of interest paid on outstanding debt plus amortization of

the debt discount and interest from capital leases.

Interest income (expense), net consists of interest income earned from bank deposits and interest expense consists of interest paid on outstanding debt plus amortization of the

debt discount and interest from capital leases.

These amounts will fluctuate based on changes to the interest rate environment.

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December 31, 2023.

The decrease of $1.7 million was primarily attributable to a decrease in quality and manufacturing costs of $10.2 million, mainly driven by the $10.0 million purchase in 2022 of the rights to PDS01ADC from Merck KGaA,

Darmstadt Germany, offset by an increase in personnel costs of $2.1 million, clinical costs of $6.1 million, facilities costs of $0.2 million, and professional fees of $0.1 million.

The decrease of $5.2 million was primarily attributable to decreases in clinical costs of $4.1 million, personnel costs of $1.0 million and professional fees of $0.1 million.

General and Administrative Expenses

For the year ended December 31, 2023, general and administrative expenses increased to approximately $15.3 million compared to approximately $12.2 million for the year ended

For the year ended December 31, 2024, general and administrative expenses decreased to approximately $13.8 million compared to approximately $15.3 million for the year ended

December 31, 2023.

The $3.1 million increase was primarily attributable to an increase in personnel costs of $1.5 million and an increase in professional fees of $1.6 million.

The $1.5 million decrease was primarily attributable to decreases in professional fees of $1.3 million, and facilities costs of $0.2 million.

Interest Income (Expense), net

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The $0.5 million increase in interest

expense was due to the Horizon Financing Loan, which was entered into in August 2022.

expense was due to the Loan and Security Agreement.

For the year ended December 31, 2024, interest income was $2.5 million compared to $2.9 million for the year ended December 31, 2023.

The increase of $2.0 million in interest

income is due to the higher cash balance resulting from the Horizon Financing Loan.

The decrease of $0.4 million in interest

income was due to lower cash balances.

Benefit from Income Taxes

Income tax benefit was $0.9 million for the year ended December 31, 2024 as compared to $1.4 million for the prior year ended December 31, 2023.

The increase of $0.2 million was

due to increased proceeds from the net sale of tax benefits to an unrelated, profitable New Jersey corporation pursuant to the Company’s participation in the New Jersey Technology Business Tax Certificate Transfer Net Operating Loss (NOL)

The decrease of $0.5 million was

due to decreased proceeds from the net sale of tax benefits to an unrelated, profitable New Jersey corporation pursuant to the Company’s participation in the New Jersey Technology Business Tax Certificate Transfer Net Operating Loss (NOL)

Liquidity and Capital Resources

In April 2022, we received approximately $1.2 million from the net sale of tax benefits to an unrelated, profitable New Jersey corporation pursuant our participation in the

New Jersey Technology Business Tax Certificate Transfer NOL program for tax year 2020.

In August 2022, we filed a shelf registration statement, or the 2022 Shelf Registration Statement, with the SEC for the issuance of common stock, preferred stock, warrants,

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Riley Securities, Inc.

and BTIG, LLC, each an Agent and collectively

the Agents, with respect to an at-the-market offering program under which we may offer and sell, from time to time at our sole discretion, shares of our common stock, having an aggregate offering price of up to $50.0 million, or the Placement

and BTIG, LLC, each an Agent and collectively the

Agents, with respect to an at-the-market offering program under which we may offer and sell, from time to time at our sole discretion, shares of our common stock, having an aggregate offering price of up to $50.0 million, or the Placement

Shares, through or to the Agents, as sales agents or principals.

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We will pay the

Agents a commission equal to three percent (3%) of the gross sales proceeds of any Placement Shares sold through the Agents under the Sales Agreement, and also has provided the Agents with customary indemnification and contribution rights.

are not obligated to make any sales of our common stock under the Sales Agreement.

Agents a commission equal to three percent (3%) of the gross sales proceeds of any Placement Shares sold through the Agents under the Sales Agreement, and we have also provided the Agents with customary indemnification and contribution rights.

We are not obligated to make any sales of our common stock under the Sales Agreement.

The offering of Placement Shares pursuant to the Sales Agreement will terminate upon the earlier of (i) the sale of all Placement Shares subject to the Sales

Agreement or (ii) termination of the Sales Agreement in accordance with its terms.

During the year ended December 31, 2023, we sold 2,642,269 shares of our common stock for a net value of $16.1 million pursuant to the Sales Agreement.

year ended December 31, 2022, we sold 1,238,491 shares of our common stock for a net value of $9.9 million pursuant to the Sales Agreement.

As of the date of this Annual Report, in the first quarter 2024, we sold 3,428,681 shares of our common

stock for a net value of $19.5 million pursuant to the Sales Agreement.

In August 2022, we entered into a venture loan and security agreement, or the Loan and Security Agreement, with Horizon Technology Finance Corporation, as lender and

collateral agent for itself and the other lenders.

In August 2024, the Company entered into an Amended and Restated At Market Issuance Sales Agreement, or the New Sales Agreement, with B.

Riley Securities, Inc.

Wainwright & Co., LLC, with terms that are substantially consistent with those included in the original Sales Agreement.

The New Sales Agreement superseded and replaced the Sales Agreement.

During the year ended December 31, 2024,

we sold 3,428,681 shares of common stock for a net value of $19.5 million pursuant to the Sales Agreement and 1,108,105 shares of common stock for a net value of $3.2 million pursuant to the New Sales Agreement.

For the year ended December 31,

2023, we sold 2,642,269 shares of our common stock for a net value of $16.1 million pursuant to the Sales Agreement.

As of the date of this Annual Report, in the first quarter 2025, we sold 205,350 shares of our common stock for a net value of

$0.30 million pursuant to the New Sales Agreement.

In August 2022, we entered into a venture loan and security agreement, or the Loan and Security Agreement, with Horizon Technology Finance Corporation, as lender and collateral

agent for itself and the other lenders.

The Loan and Security Agreement provides for the following 6 separate and independent term loans:

(a) a term loan in the amount of $7,500,000, or Loan A, (b) a term loan in the amount of

$10,000,000, or Loan B, (c) a term loan in the amount of $3,750,000, or Loan C, (d) a term loan in the amount of $3,750,000, or Loan D, (e) a term loan in the amount of $5,000,000, or Loan E, and (f) a term loan in the amount of $5,000,000, or

Loan F, (with each of Loan A, Loan B, Loan C, Loan D, Loan E, and Loan F, individually a Loan and, collectively, the Loans).

(a) a term loan in the amount of $7,500,000, or Loan A, (b) a term loan in the amount of $10,000,000, or

Loan B, (c) a term loan in the amount of $3,750,000, or Loan C, (d) a term loan in the amount of $3,750,000, or Loan D, (e) a term loan in the amount of $5,000,000, or Loan E, and (f) a term loan in the amount of $5,000,000, or Loan F, (with

each of Loan A, Loan B, Loan C, Loan D, Loan E, and Loan F, individually a Loan and, collectively, the Loans).

Loan A, Loan B, Loan C, and Loan D were delivered to us on August 24, 2022.

In total, we received $24.6 million in net

In total, we received $24.6 million in net proceeds.

Loan E and Loan F were uncommitted Loans that could have been advanced by the lenders upon the parties agreement prior to July 31, 2023 upon the satisfaction of certain conditions.

At this time the option to advance Loan E and Loan F

has expired and Loan E and Loan F are no longer available to the Company under the Loan and Security Agreement.

At this time the option to advance Loan E and Loan F has

expired and Loan E and Loan F are no longer available to the Company under the Loan and Security Agreement.

We may only use the proceeds of the Loans for working capital or general corporate purposes.

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anniversary following the applicable funding date unless accelerated pursuant to agreed upon events of default.

Payments on the principal balance begin on October 1, 2024 and are paid monthly in the succeeding 24 months.

Payments on the principal balance began on October 1, 2024 and are paid monthly in the succeeding 24 months.

The principal balance

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stated maturity date.

In connection with the Loan and Security Agreement, we issued Horizon Technology Finance Corporation and Powerscourt Investments XXV, LP warrants to purchase an aggregate

total of 381,625 shares of the Company’s common stock at an initial exercise price of $3.6685 per share.

Each warrant is classified as equity and is exercisable at any time for a period beginning on the date of grant and ending on the earlier

of (A) 10 years from the date of grant, and (B) the closing of (A) (i) the sale, lease, exchange, conveyance or other disposition of all or substantially all of the our property or business, or (ii) its merger into or consolidation with any

other corporation (other than a wholly-owned subsidiary of the Company), or any transaction (including a merger or other reorganization) or series of related transactions, in which more than 50% of the voting power of the Company is disposed

of, in each case, for cash or for marketable securities meeting certain requirements as described in the applicable warrants.

The key assumptions used in Black-Scholes option pricing model were (i) expected term of 10 years, (ii) a risk-free

rate of 3.11%, (iii) expected volatility of 93.8%, (iv) and no estimated dividend yield.

In April 2023, we received approximately $1.4 million from the net sale of tax benefits to an unrelated, profitable New Jersey corporation pursuant our participation in the

New Jersey Technology Business Tax Certificate Transfer NOL program for tax year 2021.

In connection with the Loan and Security Agreement, we issued Horizon Technology Finance Corporation and Powerscourt Investments XXV, LP warrants to purchase an aggregate total

of 381,625 shares of the Company’s common stock at an initial exercise price of $3.6685 per share.

Each warrant is classified as equity and is exercisable at any time for a period beginning on the date of grant and ending on the earlier of (A)

10 years from the date of grant, and (B) the closing of (A) (i) the sale, lease, exchange, conveyance or other disposition of all or substantially all of the our property or business, or (ii) its merger into or consolidation with any other

corporation (other than a wholly-owned subsidiary of the Company), or any transaction (including a merger or other reorganization) or series of related transactions, in which more than 50% of the voting power of the Company is disposed of, in

each case, for cash or for marketable securities meeting certain requirements as described in the applicable warrants.

The key assumptions used in Black-Scholes option pricing model were (i) expected term of 10 years, (ii) a risk-free rate of

3.11%, (iii) expected volatility of 93.8%, (iv) and no estimated dividend yield.

In April 2023, we received approximately $1.4 million from the net sale of tax benefits to an unrelated, profitable New Jersey corporation pursuant our participation in the New

Jersey Technology Business Tax Certificate Transfer NOL program for tax year 2021.

In April 2024, we received approximately $0.9 million from the net sale of tax benefits to an unrelated, profitable New Jersey corporation pursuant our participation in the New

Jersey Technology Business Tax Certificate Transfer NOL program for tax year 2022.

As of December 31, 2024, we had $41.7 million of cash and cash equivalents.

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Cash used to fund operating expenses is impacted by the timing of when we pay these expenses, as reflected in the change in our outstanding accounts payable and accrued expenses.

We evaluated whether there are any conditions and events, considered in the aggregate, that raise substantial doubt about our ability to continue as a going concern within

one year beyond the filing of this Annual Report on Form 10-K.

In February 2025, we entered into a Securities Purchase Agreement with certain purchasers, pursuant to which we agreed to sell an aggregate of 6,396,787 shares of common stock,

pre-funded warrants to purchase up to an aggregate of 933,334 shares of common stock, and common stock warrants to purchase up to an aggregate of 7,330,121 shares of common stock at a combined purchase price of $1.50 per share and warrant, the

February 2025 Offering.

Two of our directors participated in the February 2025 Offering and purchased 30,121 shares of common stock in the aggregate at an offering price per share of $1.66 and common stock warrants to purchase 30,121 shares of

common stock.

The common stock warrants issued to our directors have an exercise price per share of $1.53, but are otherwise identical to the common stock warrants issued to all other participants in the February 2025 Offering.

gross proceeds from the February 2025 Offering were approximately $11 million.

Net proceeds to us from the February 2025 Offering, after deducting the placement agent fees and other estimated offering expenses payable by the Company, were

approximately $10.05 million.

The February 2025 Offering closed on February 28, 2025.

We evaluated whether there are any conditions and events, considered in the aggregate, that raise substantial doubt about our ability to continue as a going concern within one

year beyond the filing of this Annual Report on Form 10-K.

Our budgeted cash requirements in 2025 and beyond include expenses related to continuing development and clinical studies as well as payments on our debt.

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development or future commercialization efforts or grant rights to develop and market immunotherapies that we would otherwise prefer to develop and market ourselves.

In addition, the Loan and Security Agreement also allows for the lenders to call

the outstanding balance of the term loans if the minimum cash balances outlined in the Loans and Security Agreement are not maintained.

In addition, the Loan and Security Agreement allows for the lenders to call the

outstanding balance of the term loans if the minimum cash balances outlined in the Loans and Security Agreement are not maintained.

Any of these actions could harm our business, results of operations and prospects.

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Net cash used in operating activities

Net cash used in investing activities

Net cash provided by financing activities

Net (decrease) increase in cash and cash equivalents

Net decrease in cash and cash equivalents

Net Cash Used in Operating Activities

Net cash used in operating activities was $35.0 million and $33.6 million for the years ended December 31, 2024 and 2023, respectively.

The increase in cash

used in operating activities of $7.9 million is primarily due to the increase in net loss of $2.1 million, reduced by the increase in non-cash stock-based compensation expense of $2.4 million, the value of shares issued from our consulting

agreement of $1.0 million and the value of the shares issued for the Merck licensing agreement of $5.0 million, offset by changes in the timing of working capital requirements, including changes in prepaid expenses and other assets,

accrued expenses and accounts payable.

The increase in net cash used in

operating activities of $1.4 million was primarily due to changes in the timing of working capital requirements, including changes in accrued expenses and accounts payable, offset by a decrease in net loss of $5.3 million, a decrease in

non-cash stock-based compensation expense of $0.8 million, and a decrease in the value of shares issued from our consulting agreement of $0.8 million.

Net Cash Used in Investing Activities

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Net Cash Provided by Financing Activities

Net cash provided by financing activities for the year ended December 31, 2023 was primarily due to the receipt of net proceeds from the issuance of common stock of $16.1

million and the exercise of stock options of $0.3 million.

Net cash provided by financing activities for the year ended December 31, 2022 was primarily due to the receipt of net proceeds from the issuance of the note payable of $24.6

million and the issuance of common stock of $9.9 million.

Net cash provided by financing activities for the year ended December 31, 2024 was primarily due to the receipt of net proceeds from the issuance of common stock of $22.6 million

and the exercise of stock options of $0.8 million, offset by the principal repayment of $3.1 million on the Loan and Security Agreement.

Net cash provided by financing activities for the year ended December 31, 2023 was primarily due to the receipt of net proceeds from the issuance of common stock of $16.1 million

and the exercise of stock options of $0.3 million.

Operating Capital Requirements

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substantial additional funding in connection with our continuing operations.

We evaluated whether there are any conditions and events, considered in the aggregate, that raise substantial doubt about our ability to continue as a going

concern within one year after the filing of this Annual Report.

We evaluated whether there are any conditions and events, considered in the aggregate, that raise substantial doubt about our ability to continue as a going concern

within one year after the filing of this Annual Report.

Our budgeted cash requirements in 2025 and beyond include expenses related to continuing development and clinical studies as well as payments on our debt .

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These financial resources may not be adequate to sustain our operations.

intend to finance our cash needs principally through collaborations, strategic alliances, or license agreements with third parties and/or debt or equity financings, there is no assurance that new financing will be available to us on

commercially acceptable terms or in the amounts required, if at all.

In addition, the Loan and Security Agreement also allows for the lenders to call the outstanding balance of the term loans if the minimum cash balances outlined in the Loans

and Security Agreement are not maintained.

We have concluded that substantial doubt exists about our ability to continue as a going concern for a period of at least 12 months from the date of the issuance of these audited consolidated financial

We have based our projections of operating capital requirements on assumptions that may prove to be incorrect and we may use all of our available capital resources sooner

than we expect.

While we intend to

finance our cash needs principally through collaborations, strategic alliances, or license agreements with third parties and/or debt or equity financings, there is no assurance that new financing will be available to us on commercially

acceptable terms or in the amounts required, if at all.

In addition, the Loan and Security Agreement allows for the lenders to call the outstanding balance of the term loans if the minimum cash balances outlined in the Loans and Security

Agreement are not maintained.

We have based our projections of operating capital requirements on assumptions that may prove to be incorrect and we may use all of our available capital resources sooner than we

Because of the numerous risks and uncertainties associated with research, development and commercialization of pharmaceutical products, we are unable to estimate the exact amount of our operating capital requirements.

funding requirements will depend on many factors, including, but not limited to:

Our future funding

requirements will depend on many factors, including, but not limited to:

the initiation, progress, timing, costs and results of our planned clinical trials;

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We did not have during the periods presented, and we do not currently have any off-balance sheet arrangements, as defined under U.S.

GAAP or under the rules and regulations

GAAP or under the rules and regulations of the

Smaller Reporting Company

We are a “smaller reporting company,” as defined in Rule 12b-2 under the Securities Exchange Act of 1934, as amended.

We will cease to be a smaller reporting company if we

have a non-affiliate public float in excess of $250 million and annual revenues in excess of $100 million, or a non-affiliate public float in excess of $700 million, determined on an annual basis.

As a smaller reporting company, we are

permitted and intend to rely on exemptions from certain disclosure requirements that are applicable to other public companies that are not smaller reporting companies.

We will cease to be a smaller reporting company if we have

a non-affiliate public float in excess of $250 million and annual revenues in excess of $100 million, or a non-affiliate public float in excess of $700 million, determined on an annual basis.

As a smaller reporting company, we are permitted and

intend to rely on exemptions from certain disclosure requirements that are applicable to other public companies that are not smaller reporting companies.

These exemptions include:

5 unchanged sentences

We expect to continue to take advantage of some or all of the available exemptions.

Quantitative and qualitative disclosures about market risk

Interest Rate Risk

We are exposed to market risk related changes in interest rates.

As of December 31, 2023, our cash equivalents consisted of bank

deposits and money market accounts.

Additionally, the principal balance of our Loan and Security agreement with Horizon Technology Finance Corporation bears a floating interest pegged to the prime rate.

Our primary exposure to market risk is

interest income sensitivity, which is affected by changes in the general level of U.S.

interest rates.

Historically, the net impact of fluctuations in interest rates have not been material to us.

Inflation Risk

Inflation generally affects us by increasing our cost of labor and pricing of contracts.

As a majority of our outside contracts for services and goods extend over multiple years, we do not

believe that inflation has had a material effect on our business, financial condition, or results of operations during the year ended December 31, 2023.

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 7. Management’s Discussion and Analysis